SKP.L Regulatory News (SKP)

AGM Trading Update

LONDON, UK, 18 May, 2016 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug development company, provides an update ahead of its Annual General Meeting (AGM) being held today.

Trading update

Overall trading performance to the end of April has been good and the Board continues to expect strong growth in revenues for the full year 2016 compared with 2015.

flutiform® continues to benefit from growing demand and is now launched in 31 countries, approved in a further 7 and has applications for marketing authorisations under review in 16. Good progress has also been made to broaden the approved indication, with the final patient visits in both the Europe and Asia/China COPD studies expected to conclude shortly and filings anticipated in due course. In March 2016, Mundipharma received confirmation that its application for marketing authorisation in Europe for the breath-actuated version of flutiform® had been accepted for review. In April 2016, Mundipharma was informed by the China Food and Drug Administration that its application to conduct clinical trials for flutiform® in patients with asthma aged 12 and over had been accepted. On 12 May Kyorin reported gross sales of flutiform® in Japan of Yen 7.2 billion (£46.2 million1) for the year ended 31 March 2016, an increase of 99.8 percent compared with the previous year.

Fougera Pharmaceuticals Inc. (part of Sandoz), the Group's U.S. license partner for Solaraze® and its authorised generic, reported combined first quarter sales ahead of Skyepharma's expectations as the strong demand seen in 2015 continued due to exceptional market factors. 

On 27 April, GlaxoSmithKline (GSK) reported total Q1 2016 sales of Breo®/Relvar® Ellipta®, Anoro® Ellipta® and Incruse® Ellipta® of £166 million, up from £138 million in Q4 2015. Skyepharma has the potential to earn significant royalty income of up to £9 million per annum from the licensing of inhalation technologies used in these products. Based on forecasts by analysts covering GSK, this cap is expected to be achieved in 2017.

On 2 May, Pacira announced sales of EXPAREL® of U.S.$63.8 million for Q1 2016, an increase of 14 percent compared with the first quarter of 2015. The company also confirmed its plans to launch the product for oral surgery later in the year and the initiation of two Phase III clinical trials that will serve as the basis of its intended supplemental New Drug Application (sNDA) to be filed for EXPAREL® for use in nerve block to provide post-surgical analgesia. Skyepharma receives 3 percent of net sales (on a cash received basis) of EXPAREL®. In addition, based on forecasts by analysts covering Pacira, the Group expects to receive a U.S.$8.0 million (£5.6 million1) milestone in 2016 which is due to be triggered when annual net sales (on a cash received basis) reach U.S.$250 million.

As reported in March 2016, the Group has sold a surplus facility in Muttenz, Switzerland, for CHF 9.8 million (£6.9 million at the time) and expects to record an exceptional profit on the sale of CHF 1.3 million (£0.9 million) in its full year 2016 results. The first tranche of sale proceeds amounting to CHF 6.5 million (£4.6 million) has been received and the associated mortgage repaid, and the second and final tranche of CHF 3.3 million (£2.3 million) is expected during the second half of 2016.

Development pipeline

The initial work around feasibility of the development of the ICS/LABA/LAMA2 triple combination product SKP-2076, has been completed on schedule. Further work is on-going and the group is in detailed negotiations with Mundipharma over the terms of a potential exclusive global development and license agreement, based on the heads of terms already established, under which, if entered into, Mundipharma would complete the development of, and commercialise, SKP-2076.

Good progress has also been made with pre-clinical studies for SKP-2075 (theophylline/fluticasone combination for COPD/Smoking Asthma) and the first clinical study is expected to start later this year.

In the oral pipeline, a pharmacokinetic study has been carried out on Skyepharma's novel gastroretentive technology, Oleotec®, and data generated is now being analysed.

Recommended all-share Merger with Vectura Group Plc

As announced on 5 May 2016, Skyepharma shareholders voted overwhelmingly at the Court Meeting to approve the Scheme and at the Skyepharma General Meeting to pass the Special Resolution to approve and implement the Scheme. On the same day, Vectura shareholders at the Vectura General Meeting also voted overwhelmingly in favour of a resolution to approve the Merger. On 16 May 2016, the Competition and Markets Authority (the "CMA") confirmed that the proposed recommended Merger of Vectura and Skyepharma does not qualify for investigation under the Enterprise Act 2002. This confirmation satisfies the CMA clearance condition to the implementation of the proposed Merger. In the meantime, senior management from both Skyepharma and Vectura have commenced joint planning within the constraints of the Merger process and anti-trust restrictions in order to ensure a smooth transition for the Enlarged Group following completion. Capitalised terms used but not defined in this paragraph have the meanings set out in the circular posted to Skyepharma Shareholders in connection with the Scheme on 8 April 2016 (the "Scheme Document").

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"We remain on track to deliver further strong growth in revenues in 2016, with increased demand for flutiform, Pacira's EXPAREL and the GSK Ellipta products incorporating Skyepharma technology. Important clinical studies to expand the successful flutiform franchise are nearing completion and the Group is also making good progress with its promising pipeline of inhalation and oral products and technologies.

Following the overwhelming shareholder vote earlier this month in support of the Board's recommended all-share merger with Vectura, we look forward to the future with confidence."

Skyepharma will hold its AGM today at 10.30 a.m. at the offices of FTI Consulting, 200 Aldersgate Street, London EC1A 4HD.

-Ends-

1. Using exchange rate as at 16 May 2016

2. ICS - Inhaled corticosteroid. LABA - Long-acting beta agonist. LAMA - Long-acting muscarinic agonist

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About Skyepharma

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 16 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.skyepharma.com 

Important notices

Capitalised terms used but not defined in the following paragraphs have the meanings set out in the Scheme Document.

Further information

This announcement is for information purposes only and is not intended to, and does not, constitute or form part of any offer, invitation, inducement or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of or exercise rights in respect of any securities, or the solicitation of any vote or approval of an offer to buy securities in any jurisdiction, pursuant to the Merger or otherwise. The Merger is to be implemented by way of the Scheme pursuant to the terms of the Scheme Document, which contains the full terms and conditions of the Merger. Any decision or other response in respect of the Merger should be made only on the basis of information contained in the Scheme Document.

Overseas jurisdictions

The release, publication or distribution of this announcement in, into or from jurisdictions other than the United Kingdom may be restricted by the laws of those jurisdictions and therefore persons into whose possession this announcement comes should inform themselves about, and observe, any applicable restrictions. Any failure to comply with such restrictions may constitute a violation of the securities laws of such jurisdictions.

This announcement is not intended to, and does not, constitute or form part of any offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities or the solicitation of any vote or approval pursuant to the Scheme or otherwise, in any jurisdiction in which such offer, invitation or solicitation is unlawful. 

The implications of the Merger for persons resident in, or citizens of, jurisdictions outside the United Kingdom may be affected by the laws of the relevant jurisdictions. Such Overseas Shareholders should inform themselves about and observe any applicable legal requirements. It is the responsibility of each Overseas Shareholder to satisfy itself as to the full observance of the laws of the relevant jurisdiction in connection therewith, including the obtaining of any governmental, exchange control or other consents which may be required, or the compliance with other necessary formalities which are required to be observed and the payment of any issue, transfer or other taxes due in such jurisdiction.

Overseas Shareholders should consult their own legal and tax advisers with regard to the legal and tax consequences of the Scheme to their particular circumstances. All Skyepharma Shareholders (including, without limitation, nominees, trustees or custodians) who would, or otherwise intend to, forward this announcement to any jurisdiction outside the United Kingdom, should seek appropriate independent professional advice before taking any action.

Forward looking statements

This announcement, including information included or incorporated by reference in this announcement, may contain certain "forward looking statements" regarding the financial position, business strategy or plans for future operations of the Skyepharma Group. All statements other than statements of historical fact included in any document may be forward looking statements. Forward looking statements also often use words such as "expect", "expectations", "intend", "anticipate", "forecast" and words of a similar meaning. By their nature, forward looking statements involve risk and uncertainty that could cause actual results to differ materially from those suggested by them. Much of the risk and uncertainty relates to factors that are beyond the Skyepharma Group's ability to control or estimate precisely, such as future market conditions and the behaviours of other market participants, and therefore undue reliance should not be placed on such statements which speak only as at the date of this announcement. The Skyepharma Group does not assume any obligation to, and does not intend to, revise or update these forward looking statements, except as required pursuant to applicable law or regulation.

Publication on website

A copy of this announcement will be made available, free of charge and subject to certain restrictions relating to persons resident in restricted jurisdictions, on Skyepharma's website at www.skyepharma.com by no later than 12 noon (London time) on the Business Day following the date of this announcement. For the avoidance of doubt, neither the content of the Skyepharma website nor any website accessible by hyperlinks to the Skyepharma website are incorporated into, or form part of, this announcement.

Other

If you are in any doubt about the contents of this announcement or any action you should take in connection therewith, you are recommended to seek your own independent financial advice immediately from your stockbroker, bank manager, solicitor, accountant or from an independent financial adviser duly authorised under the Financial Services and Markets Act 2000 (as amended) if you are resident in the United Kingdom or, if not, from another appropriately authorised independent financial adviser.